NA 03.108.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982071552), received between Jul 17, 2018 and Mar 11, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (18 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2025Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE TIMING OF THE REPORTED EVENT WAS DURING POST-OP. THE OPERATION WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT INSTRUMENT SET. NO OTHER COMPLAINT NEEDS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21571257 ↗
• MalfunctionNov 27, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS A 40 MINUTES SURGICAL DELAY AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20795616 ↗
• MalfunctionFeb 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2024, THAT ACCORDING TO THE CUSTOMER'S DESCRIPTION, THE K-WIRE IS JAMMED IN THE TARGET BLOCK DURING AN ONGOING SURGERY. NO PATIENT INFORMATION AVAILABLE. NO PATIENT HARM. SURGERY COMPLETED WITH OTHER DEVICE. THIS REPORT IS FOR ONE (1) K-WIRE Ø2.8 W/SPADE POINT TIP THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18767869 ↗
• MalfunctionFeb 14, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THE WIRE REPEATEDLY PINCHED WHEN PLUGGED IN THROUGH THE GUIDE BLOCK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF APPROXIMATELY 10-15 MINUTES. PATIENT OUTCOME WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18705334 ↗
• MalfunctionFeb 14, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THERE WAS A SURGICAL DELAY OF APPROXIMATELY 10-15 MINUTES. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18704829 ↗
• MalfunctionFeb 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON JANUARY 5, 2024, THE K-WIRE IS JAMMED IN THE TARGET BLOCK DURING AN ONGOING SURGERY. THIS HAD ALREADY HAPPENED TWICE BEFORE (IN 2023), BUT THE TARGET BLOCKS WERE SIMPLY REPLACED BECAUSE IT WAS ASSUMED THAT IT WAS A HANDLING ERROR. NOW THE PROBLEM OCCURRED AGAIN AND, IT WAS NOT A USER ERROR BECAUSE THERE ARE SEVERAL ORS OPERATING IN TWO DEPARTMENTS. THERE WAS NO REPORTED PATIENT HARM. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. THIS REPORT INVOLVES ONE (1) 2.8MM KIRSCHNER WIRE SPADE POINT 200MM. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4) IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18687042 ↗
• MalfunctionFeb 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT THE 2.8 GUIDE WIRE FOR THE AIMING BLOCK WAS STUCK INSIDE THE GUIDE. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) UNK - GUIDE/COMPRESSION/K-WIRES. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18627633 ↗
• MalfunctionJan 30, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT A CORRECTIVE OSTEOTOMY FOR A VARUS DEFORMITY OF THE PROXIMAL FEMUR. THE SURGEON INSERTED THE GUIDEWIRE USING THE AIMING BLOCK. WHEN THE SURGEON TRIED TO PULL OUT THE GUIDEWIRE TO ADJUST ITS POSITION, IT GOT STUCK IN THE AIMING BLOCK AND COULD NOT BE PULLED OUT OR INSERTED. THE SURGERY WAS PERFORMED BY OTHER TECHNIQUES AND WAS COMPLETED WITHOUT PROBLEMS WITHIN A 30 MINUTE DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 2.8MM KIRSCHNER WIRE SPADE POINT 200MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607223 ↗
• MalfunctionSep 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE 2.8 WIRE HAS WELDED INTO THE GUIDE BLOCK HOLES, THIS IS THE 4TH TIME THIS HAS HAPPENED. ANOTHER SET OPENED. 30 MINUTE DELAY IN SURGERY. NO PATIENT IMPACT. THIS REPORT IS FOR A 2.8MM KIRSCHNER WIRE SPADE POINT 200MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15335977 ↗
• MalfunctionSep 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE 2.8 WIRE HAS WELDED INTO THE GUIDE BLOCK HOLES, THIS IS THE 4TH TIME THIS HAS HAPPENED. ANOTHER SET OPENED. 30 MINUTE DELAY IN SURGERY. NO PATIENT IMPACT. THIS REPORT IS FOR A 2.8MM KIRSCHNER WIRE SPADE POINT 200MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15335703 ↗
• MalfunctionSep 1, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE 2.8 WIRE HAS WELDED INTO THE GUIDE BLOCK HOLES, THIS IS THE 4TH TIME THIS HAS HAPPENED. ANOTHER SET OPENED. 30 MINUTE DELAY IN SURGERY. NO PATIENT IMPACT. THIS REPORT IS FOR A 2.8MM KIRSCHNER WIRE SPADE POINT 200MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15335247 ↗
• MalfunctionAug 31, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT 2.8 WIRE HAS WELDED INTO THE GUIDE BLOCK HOLES, THIS IS THE 4TH TIME THIS HAS HAPPENED. ANOTHER SET OPENED. 30 MINUTE DELAY IN SURGERY. NO PATIENT IMPACT. THIS REPORT IS FOR ONE (1) K-WIRE ø2.8 W/SPADE POINT TIP. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328765 ↗
• MalfunctionApr 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 1 OF 5 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT TWO K-WIRE DEVICES JAMMED IN EACH GUIDE (03.108.001 AND 03.108.002) AND THE PLATE DEVICE WAS USED AS A GUIDE INSTEAD. IT WAS FURTHER REPORTED THAT DURING REMOVAL OF WIRES LATER, THE EXTENDER ALSO APPEARED DAMAGED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) K-WIRE Ø2.8 W/SPADE POINT TIP DEVICE. THIS COMPLAINT INVOLVES FIVE (5) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14196614 ↗
• MalfunctionApr 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 2 OF 5 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT TWO K-WIRE DEVICES JAMMED IN EACH GUIDE (03.108.001 AND 03.108.002) AND THE PLATE DEVICE WAS USED AS A GUIDE INSTEAD. IT WAS FURTHER REPORTED THAT DURING REMOVAL OF WIRES LATER, THE EXTENDER ALSO APPEARED DAMAGED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) K-WIRE Ø2.8 W/SPADE POINT TIP DEVICE. THIS COMPLAINT INVOLVES FIVE (5) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14196584 ↗
• MalfunctionDec 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT (B)(6) 2021, DURING A PROCEDURE THE INSTRUMENTS BECAME STUCK TOGETHER. THERE WAS A TEN (10) MINUTE SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) 2.8MM KIRSCHNER WIRE SPADE POINT 200MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112489 ↗
• MalfunctionNov 8, 2021Material Deformation; Scratched Material; Material Deformation; Scratched Material

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A LEFT LOWER LIMB RECONSTRUCTIVE SURGERY, TWO (2) 2.8MM K-WIRES STRIPPED AND PARTIALLY BENT OVER THEIR ENTIRE LENGTH AND ONE (1) 2.0MM K-WIRE BENT AND STRIPPED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 2.8MM KIRSCHNER WIRE SPADE POINT 200MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775273 ↗
• MalfunctionNov 8, 2021Material Deformation; Scratched Material; Material Deformation; Scratched Material

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A LEFT LOWER LIMB RECONSTRUCTIVE SURGERY, TWO (2) 2.8MM K-WIRES STRIPPED AND PARTIALLY BENT OVER THEIR ENTIRE LENGTH AND ONE (1) 2.0MM K-WIRE BENT AND STRIPPED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 2.8MM KIRSCHNER WIRE SPADE POINT 200MM. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775185 ↗
• MalfunctionOct 5, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT BEFORE THE SURGERY, IT WAS CONFIRMED THAT THE KIRSCHNER WIRE WAS STUCK AND COULD NOT BE INSERTED SMOOTHLY WHEN THE SURGEON INSERTED THE KIRSCHNER WIRE 2.8 INTO THE AIMING BLOCK. DURING THE SURGERY, THE SURGEON RE-INSERTED THE KIRSCHNER WIRE 2.8 INTO THE AIMING BLOCK SEVERAL TIMES, AND AS A RESULT, NO EVENTS OCCURRED IN WHICH THE KIRSCHNER WIRE COULD NOT BE REMOVED FROM THE AIMING BLOCK. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.8MM KIRSCHNER WIRE SPADE POINT 200MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579365 ↗
• MalfunctionSep 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021 THE PATIENT UNDERWENT THE OPEN REDUCTIONAL INTERNAL FIXATION SURGERY FOR PROXIMAL FEMUR WITH THE AIMING BLOCK AND 2.8MM KIRSCHNER WIRE. DURING THE SURGERY WITH LOCKING COMPRESSION PLATE (LCP) PEDIATRIC HIP PLATE, THE SURGEON SMOOTHLY COMPLETED THE PROCEDURE OF PASSING THE POSITIONING WIRE 2.0MM THROUGH THE POSITIONER FOR AIMING BLOCK AND PROCEEDED TO THE NEXT STEP, THE STEP OF PASSING THE KIRSCHNER WIRE 2.8MM THROUGH THE AIMING BLOCK, BUT THERE WAS A FEELING OF DISCOMFORT WHEN INSERTING THE KIRSCHNER WIRE 2.8MM AND HARD TO INSERT. HOWEVER, IT WAS FORCEFULLY INSERTED. AS A RESULT OF FORCED INSERTION, KIRSCHNER WIRE 2.8MM COULD NOT BE REMOVED FROM THE AIMING BLOCK AND THE SURGEON DECIDED NOT TO USE THEM. THE SURGERY WAS PERFORMED FREEHAND BY THE SURGEON AND WAS COMPLETED SUCCESSFULLY WITHIN THIRTY (30) MINUTES DELAY. THE PATIENT OUTCOME IS REPORTED AS STABLE. THE SURGEON COMMENTED THAT HE PREVIOUSLY EXPERIENCED DISCOMFORT WHEN INSERTING KIRSCHNER WIRE 2.8 MM INTO THE AIMING BLOCK. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.8MM KIRSCHNER WIRE SPADE POINT 200MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12556661 ↗
• MalfunctionAug 25, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE THE K-WIRE BECAME STUCK IN THE AIMING BLOCK. ANOTHER SET WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. THERE WAS NO CONSEQUENCE TO THE PATIENT. THIS REPORT INVOLVES ONE (1) 2.8MM KIRSCHNER WIRE SPADE POINT 200MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12365083 ↗
• MalfunctionJul 17, 2018Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, A 2.8MM KIRSCHNER WIRE BECAME STUCK INSIDE THE PEDIATRIC LOCKING COMPRESSION PLATE (LCP) HIP PLATE GUIDING BLOCK. ANOTHER UNKNOWN WIRE ALSO BECAME STUCK INSIDE ANOTHER GUIDING BLOCK. BACKUP INSTRUMENTS WERE USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 15 MINUTES. THIS REPORT IS FOR ONE (1) 2.8MM KISCHNER WIRE. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7693563 ↗